Maggie Chen Email and Phone Number

Manage SMO business in Taiwan including but not limited to Site Management Unit and Phase I Unit.Responsible for SMO business in Taiwan including management of organization’s financial aspect and implementing business efficiencies so that all Key Performance Indicators (KPIs) are met and target revenues are achieved.Lead SMO sales activities in collaboration with Business Development team to seek and pursue local and regional business opportunities, contributing to the development of promotional materials and project proposals.Lead internal/external audits and regulatory inspections. Responsible for managing all activities performed within the responsible business units are compliant to ICH-GCP, SOPs and local regulation.

Overall accountability for the execution of the clinical project. Responsible for coordinating the functional team members and liaising with the sponsor to ensure that the project deliverables are met.Manage the sponsor relationship and seek support in communicating with concerns.Develop and maintain a project plan with key milestones and budgets. Identify potential risks and implement contingency plans with project team members and keep sponsor informed.Monitor the quality of the project and implement corrective and preventative action when needed.

* Professional and Management skills：1. Plan and conduct audits for clinical trials to ensure compliance with protocol, SOPs, and regulatory requirements. (GCP/GLP/ISO17025/CAP)2. Provide consultation to clinical project teams to compliance with GCP, GLP, ISO17025, and CAP standards.3. Conduct local and overseas CRO, medical laboratory, data backup storage, and records storage vendor evaluation audit. 4. Lead 4 QA specialists to ensure that all operations maintain compliance with SOPs, study protocols, and regulatory requirements.5. Negotiate with department heads to ensure that quality outcomes are realized.6. Manage quality assurance program, providing regular trend analysis report to upper management.* Work Summary：1. Conduct source document verification and in-process audit for clinical trials.2. Audit statistical and clinical final report to ensure compliance with protocol, SOPs and regulatory requirements.3. Audit bioanalytical and method validation reports. 4. Develop training materials and provide training sessions on regulatory compliance.5. Write and review SOPs to ensure that all operation activities maintain compliance with regulatory requirements.6. Generate audit reports and follow up the corrective action and preventive action (CAPA).7. Host sponsor audits and regulatory inspections. 8. Handle customer complaints.

1. In charge of initial application for ASHI (American Society for Histocompatibility and Immunogenetics) accreditation in 2009.2. Conduct HLA testing.